Device and method for performing electroencephalography

ABSTRACT

A device  10  for performing electroencephalography on a patient, the device comprising a sagittal portion  14  comprising: a forehead anchor  44  comprising two forehead anchor arms, a first forehead anchor arm  46  and an opposing second forehead anchor arm  48;  a neck anchor  54  comprising two neck anchor arms, a first neck anchor arm  56  and an opposing second neck anchor arm  58;  a midsection  52  between the forehead anchor and the neck anchor; and a plurality of imbedded electrodes  20  within the forehead anchor, and the midsection. The device further comprises: a coronal portion  12  comprising a plurality of imbedded electrodes; and electrical connectors  22  for electrically connecting the imbedded electrodes in the sagittal portion and the coronal portion to an electroencephalograph.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application claims priority from U.S. Provisional PatentApplication No. 60/985,926, filed on Nov. 6, 2007, entitled “Device andMethod for Performing Electroencephalography”, the contents of which areincorporated herein by reference in their entirety.

BACKGROUND

Electroencephalography is a technique for measuring the electricalactivity of the brain by recording the electrical activity fromelectrodes placed on the scalp. The graph produced byelectroencephalography is called an electroencephalogram (EEG).

Electroencephalography has a number of advantages over other diagnostictechniques, such as magnetic resonance imaging, in thatelectroencephalography records the electrical activity of the brain anddoes not require the patient to remain still for extended periods.Electroencephalography is generally performed by placing electrodes onthe scalp using a conductive gel or paste, where each electrode isattached to an individual wire which isolates the activity at theposition of the electrode. The names and locations of the electrodes areusually specified using the International 10-20 system for consistencybetween institutions, where 21 electrodes are used in testing an adult.A ground electrode or a ground electrode and a reference electrode arealso generally used in testing.

There are a number of potentially treatable conditions whichelectroencephalography can diagnose through characteristicelectroencephalogram patterns. Among these conditions are non-convulsivestatus epilepticus (NCSE), seizure and stroke. It is difficult todiagnose brain injuries such as NCSE and strokes in many patients,particularly those who have altered mental status or who are comatosewithout performing electroenchalography.

Disadvantageously, however, specially trained technicians are often notavailable to apply electroencephalography electrodes so thatelectroencephalography can be performed in every location and at alltimes. Therefore, electroencephalography as a diagnostic technique isunderutilized, such as in the emergency room (ER), Intensive Care Unit(ICU), operating room (OR), at accident scenes and in a battlefieldsituation. Further, routine electroencephalography as a part of aprimary medical examination is generally not performed, in part becauseof the difficulty of placing the electrodes properly. Additionally,currently used electroencephalography devices are costly to produce, andare therefore cleaned between uses so that the devices can be reused onother patients. The cleaning and disinfecting process is time consuming.

Therefore, there is a need for a device for performingelectroencephalography which is not associated with the disadvantages ofcurrently used devices.

SUMMARY

According to one embodiment of the present invention, there is provideda device for performing electroencephalography on a patient. The devicecomprises a sagittal portion comprising: i) a forehead anchor comprisingtwo arms, a first forehead anchor arm and an opposing second foreheadanchor arm; ii) a neck anchor comprising two arms, a first neck anchorarm and an opposing second neck anchor arm; iii) a midsection betweenthe forehead anchor and the neck anchor; and iv) a plurality of imbeddedelectrodes within the forehead anchor, and the midsection. The devicefurther comprises: a coronal portion comprising a plurality of imbeddedelectrodes; and electrical connectors for electrically connecting theimbedded electrodes in the sagittal portion and the coronal portion toan electroencephalograph.

In a preferred embodiment, the sagittal portion and the coronal portioncomprise a contact surface, and the contact surface comprises a siliconebased adhesive for reversibly attaching the device to the patient. Inanother preferred embodiment, the sagittal portion or the coronalportion or both the sagittal portion and the coronal portion comprise arelease film covering the contact surface. In another embodiment, theforehead anchor further comprises a third forehead anchor arm betweenthe first forehead anchor arm and the second forehead anchor arm. Inanother embodiment, the neck anchor further comprises a third neckanchor arm between the first neck anchor arm and the second neck anchorarm. In another embodiment, the imbedded electrodes in the foreheadanchor consist of electrodes positioned at positions F₇, F_(P1), F_(P2),F₈ of the International Standard 10-20 System for electrode placement.In another embodiment, the imbedded electrodes in the midsection consistof electrodes positioned at positions F_(Z), C_(Z), P_(Z), O₁ and O₂ ofthe International Standard 10-20 System for electrode placement. In apreferred embodiment, the forehead anchor further comprises a referenceelectrode or a ground electrode or a reference electrode and a groundelectrode. In a preferred embodiment, a plurality of sponges areattached to the embedded electrodes. In a further preferred embodiment,one or more than one of the plurality of sponges contains a conductivegel.

According to another embodiment of the present invention, there isprovided a device for performing electroencephalography on a patient.The device comprises a coronal portion comprising: i) a first ear anchorcomprising a front arm and a rear arm; ii) a second ear anchorcomprising a front arm and a rear arm; iii) a midsection between thefirst ear anchor and the second ear anchor; and iv) a plurality ofimbedded electrodes within the first ear anchor, the midsection and thesecond ear anchor. The device further comprises a sagittal portioncomprising a plurality of imbedded electrodes; and electrical connectorsfor electrically connecting the imbedded electrodes in the sagittalportion and the coronal portion to an electroencephalograph.

In a preferred embodiment, the sagittal portion and the coronal portioncomprise a contact surface, and the contact surface comprises a siliconebased adhesive for reversibly attaching the device to the patient. Inanother preferred embodiment, the sagittal portion or the coronalportion or both the sagittal portion and the coronal portion comprise arelease film covering the contact surface. In another embodiment, theimbedded electrode in the first ear anchor is positioned at position A₁of the International Standard 10-20 System for electrode placement. Inanother embodiment, the imbedded electrode in the second ear anchor ispositioned at position A₂ of the International Standard 10-20 System forelectrode placement. In another embodiment, the imbedded electrodes inthe midsection consist of electrodes positioned at positions T₃, C₃, C₄,and T₄ of the International Standard 10-20 System for electrodeplacement. In a preferred embodiment, a plurality of sponges areattached to the embedded electrodes. In a further preferred embodiment,one or more than one of the plurality of sponges contains a conductivegel.

According to another embodiment of the present invention there isprovided a device for performing electroencephalography on a patient,the device comprising: a sagittal portion comprising: i) a foreheadanchor comprising two arms, a first forehead anchor arm and an opposingsecond forehead anchor arm; ii) a neck anchor comprising two arms, afirst neck anchor arm and an opposing second neck anchor arm; iii) amidsection between the forehead anchor and the neck anchor; and iv) aplurality of imbedded electrodes within the forehead anchor, and themidsection. The device further comprises a coronal portion comprising:i) a first ear anchor comprising a front arm and a rear arm; ii) asecond ear anchor comprising a front arm and a rear arm; iii) amidsection between the first ear anchor and the second ear anchor; andiv) a plurality of imbedded electrodes within the first ear anchor, themidsection and the second ear anchor. The device further compriseselectrical connectors for electrically connecting the imbeddedelectrodes in the sagittal portion and the coronal portion to anelectroencephalograph.

In a preferred embodiment, the sagittal portion and the coronal portioncomprise a contact surface, and the contact surface comprises a siliconebased adhesive for reversibly attaching the device to the patient. Inanother preferred embodiment, the sagittal portion or the coronalportion or both the sagittal portion and the coronal portion comprise arelease film covering the contact surface. In a preferred embodiment, aplurality of sponges are attached to the embedded electrodes. In afurther preferred embodiment, one or more than one of the plurality ofsponges contains a conductive gel.

In another embodiment, the forehead anchor further comprises a thirdforehead anchor arm between the first forehead anchor arm and the secondforehead anchor arm. In another embodiment, the neck anchor furthercomprises a third neck anchor arm between the first neck anchor arm andthe second neck anchor arm. In another embodiment, the imbeddedelectrodes in the forehead anchor consist of electrodes positioned atpositions F₇, F_(P1), F_(P2), F₈ of the International Standard 10-20System for electrode placement. In another embodiment, the imbeddedelectrodes in the midsection consist of electrodes positioned atpositions F_(Z), C_(Z), P_(Z), O₁ and O₂ of the International Standard10-20 System for electrode placement. In a preferred embodiment, theforehead anchor further comprises a reference electrode or a groundelectrode or a reference electrode and a ground electrode. In anotherembodiment, the imbedded electrode in the first ear anchor is positionedat position A₁ of the International Standard 10-20 System for electrodeplacement. In another embodiment, the imbedded electrode in the secondear anchor is positioned at position A₂ of the International Standard10-20 System for electrode placement. In another embodiment, theimbedded electrodes in the midsection consist of electrodes positionedat positions T₃, C₃, C₄, and T₄ of the International Standard 10-20System for electrode placement.

According to another embodiment of the present invention there isprovided a device for performing electroencephalography on a patient,the device comprising: a sagittal portion comprising a plurality ofimbedded electrodes; a coronal portion comprising a plurality ofimbedded electrodes; and electrical connectors for electricallyconnecting the imbedded electrodes in the sagittal portion and thecoronal portion to an electroencephalograph. The sagittal portion andthe coronal portion each comprise a contact surface that comprises asilicone based adhesive for reversibly attaching the device to thepatient. In a preferred embodiment, the sagittal portion or the coronalportion or both the sagittal portion and the coronal portion comprise arelease film covering the contact surface.

According to another embodiment of the present invention there isprovided a method of performing electroencephalography on a patient. Themethod comprises: providing a device for performingelectroencephalography on the patient, the device comprising: a sagittalportion and a coronal portion, each of the sagittal portion and thecoronal portion comprising a plurality of imbedded electrodes; andelectrical connectors for electrically connecting the imbeddedelectrodes in the sagittal portion and the coronal portion to anelectroencephalograph.

The method further comprises affixing the device to the patient; andproducing an electroencephalogram. In a preferred embodiment, the devicecomprises a liner, and the method further comprises removing the linerbefore affixing the device. In another preferred embodiment, the devicecomprises a stabilizing strip, and affixing the device to the patientfurther comprises affixing the stabilizing strip to the sagittal portionor the coronal portion or the sagittal portion and the coronal portion,and to the patient. In an embodiment, affixing the device to the patientfurther comprises affixing the forehead anchor to the forehead of thepatient, affixing the midsection along a sagittal midline of the head ofthe patient and affixing the neck anchor to the base of the skullproximal the neck of the patient. In another embodiment, affixing thedevice to the patient further comprises affixing the first ear anchoraround the left ear of the patient and affixing the second ear anchoraround the right ear of the patient.

According to another embodiment of the present invention there isprovided a method of diagnosing a neurologic condition or disease. Themethod comprises: selecting a patient potentially with the neurologiccondition or disease. The method further comprises: providing a devicefor performing electroencephalography on the patient, the devicecomprising: a sagittal portion and a coronal portion, each of thesagittal portion and the coronal portion comprising a plurality ofimbedded electrodes; and electrical connectors for electricallyconnecting the imbedded electrodes in the sagittal portion and thecoronal portion to an electroencephalograph. The method furthercomprises: affixing the device to the patient; and producing anelectroencephalogram. In a preferred embodiment, the method furthercomprises diagnosing the neurologic condition or disease by interpretingthe electroencephalogram. In another embodiment, the method furthercomprises treating the neurologic condition or disease that isdiagnosed. In an embodiment, the neurologic condition or disease isnon-convulsive status epilepticus or an epileptic seizure or a stroke.

FIGURES

These and other features, aspects and advantages of the presentinvention will become better understood with regard to the followingdescription, appended claims, and accompanying figures where:

FIG. 1 is a drawing showing the standard placement of electrodes in thestandard 10-20 system for EEG electrode placement;

FIG. 2 is a schematic view of a device for performingelectroencephalography according to an embodiment of the presentinvention;

FIG. 3 is a cross sectional view of the device of FIG. 2 taken alongline 3-3;

FIG. 4 is a partial cut away lateral perspective view of a stabilizingstrip for use with the device of FIG. 2 according to an embodiment ofthe present invention;

FIG. 5 is a schematic view of a device for performingelectroencephalography according to an additional embodiment of thepresent invention;

FIG. 6 is a top perspective view showing placement of theelectroencephalography device of FIG. 2 on the head of a patientaccording to an embodiment of the present invention; and

FIG. 7 is a lateral perspective view showing placement of theelectroencephalography device of FIG. 2 on the head of a patientaccording to an embodiment of the present invention.

DESCRIPTION

According to one embodiment of the present invention, there is provideda device for performing electroencephalography. Preferably, theelectroencephalography device comprises an EEG headpiece made withinexpensive materials and designed to be disposable. Theelectroencephalography device comprises a self-adhesive backing andintegrated circuitry connected to self-prepping, pre-gelled imbeddedelectrodes. Preferably, the electroencephalography device utilizes amodified 10-20 electrode positioning system having fewer electrodes thanthe standard 10-20 placement for simple recording, but with sufficientEEG locations to record information over critical brain locations.

The device provides sufficient EEG channels to determine if thepatient's brain activity is normal or abnormal and to then quickly treatthe patient based on the interpretation of the EEG. Theelectroencephalography device can be easily applied by technicians orother medical personnel with minimal training, allowing theelectroencephalography device to be used in situations whereelectroencephalography is currently difficult to perform because of thecomplex placement of the electrodes, such as in the emergency room (ER),Intensive Care Unit (ICU), operating room (OR), at accident scenes andin a battlefield situation. Additionally, the electroencephalographydevice can be used to record cortical evoked potentials and EEGrecordings during sleep studies, or other studies as will be understoodby those with skill in the art with reference to this disclosure.

According to another embodiment of the present invention, there isprovided a method for performing electroencephalography. In a preferredembodiment, the method comprises providing an electroencephalographydevice according to the present invention, and recording an EEG.

According to another embodiment of the present invention, there isprovided a kit for performing electroencephalography. In one embodiment,the kit comprises an electroencephalography device according to thepresent invention. The device, method and kit will now be disclosed indetail.

As used herein, except where the context requires otherwise, the term“comprise” and variations of the term, such as “comprising,” “comprises”and “comprised” are not intended to exclude other additives, components,integers or steps.

As used in this disclosure, two elements of an electroencephalographydevice are “integral” or “integrated” if they are joined together in amanner that does not allow separation of the two elements from oneanother by the user of the device without diminishing or destroying thefunction one or both of the two elements.

All dimensions specified in this disclosure are by way of example onlyand are not intended to be limiting. Further, the proportions shown inthese Figures are not necessarily to scale. As will be understood bythose with skill in the art with reference to this disclosure, theactual dimensions of any electroencephalography device or part of anelectroencephalography device disclosed in this disclosure will bedetermined by its intended use, including being sized appropriately foruse on infants and children.

The electroencephalography device of the present invention and itscomponent parts comprise any suitable material for the intended purposeof the electroencephalography device, as will be understood by thosewith skill in the art with reference to this disclosure. Reference tospecific materials in this disclosure are by way of example only.

The electroencephalography device of the present invention and itscomponent parts can be constructed according to standard techniques, aswill be understood by those with skill in the art with reference to thisdisclosure.

Referring now to FIG. 1, a drawing showing the standard placement ofelectrodes in the standard 10-20 system for EEG electrode placement. Ascan be seen, in the standard 10-20 system for electrode placement, thereare 21 electrodes placed at positions F_(P1), F_(P2), F₇, F₃, F_(z), F₄,F₈, A₁, T₃, C₃, C_(Z), C₄, T₄, A₂, T₅, P₃, P_(Z), P₄, T₆, O₁ and O₂(given from front to back, left side to right side). In a preferredembodiment of the present invention the electrodes are placed on F_(P1),F_(P2), F₇, F_(Z), F₈, A₁, T₃, C₃, C_(Z), C₄, T₄, A₂, P_(Z), O₁ and O₂.Additionally, the electroencephalography device according to anembodiment can have one or more of a reference electrode and a groundelectrode. These electrodes are typically placed at locations F_(PZ) andAF_(Z) on a standard 10-10 system for electrode placement (not shown).

In one embodiment, the present invention is an electroencephalographydevice for performing electroencephalography. Referring now to FIG. 2,there is shown a schematic view of an electroencephalography device forperforming electroencephalography according to the present invention. Ascan be seen, the electroencephalography device 10 comprises twoportions, a coronal portion 12 depicted on the left side of FIG. 1, anda sagittal portion 14 depicted on the right side of FIG. 1. In anotherembodiment of the present invention, the coronal portion 12 and thesagittal portion 14 of the electroencephalography device 10 areintegrally connected at or near their axial midpoints.

The various components of the electroencephalography device 10 accordingto an embodiment of the present invention will now be described in moredetail with reference to FIG. 2 and FIG. 3. The device 10 has a baselayer 16. Preferably, the base layer 16 is a plastic, such as forexample a polyester material having a thickness of between about 3 andabout 5 mil. Conductive silver circuitry 18 is placed onto the outerlayer 16, such as by printing. A plurality of electrodes 20 are placedat specific locations in contact with the silver circuitry 18, such asby printing. Preferably, the electrodes 20 are silver/silver chloride.The silver circuitry 18 leads from each electrode 20 and terminates inconnectors 22. The connectors 22 are configured to mate withcorresponding connectors (not shown) on a reusable EEG interface cablewith 10-20 labeled DIN connectors that plug into any standard EEGrecording system head box with standard DIN inputs. Those of skill inthe art will recognize that other conductive materials may be used forthe circuitry 18 and the electrodes 20.

A dielectric layer 24 covers the silvers circuitry 18 and outer layer 16to insulate the circuitry. Preferably, the dielectric layer 24 is apolymer composition, has a thickness of between about 0.5 and about 2.0mil, and is printed over the silver circuitry 18 and the outer layer 16.In a preferred embodiment of the present invention, the dielectric layeris 5018 UV Curable Dielectric sold by DuPont Microcircuit Materials,Research Triangle Park, N.C. USA. A sponge adhesive 26 is placed in thearea around the electrodes 20. Sponges 28 are adhered to the spongeadhesive 26, thereby imbedding the sponges 28 in contact with theelectrodes 20.

An acrylic adhesive layer 30 covers the dielectric layer 24. The acrylicadhesive layer 30 has a thickness of between about 1 and about 3 mil. Afilm layer 32 covers the acrylic adhesive 30. In an embodiment the filmlayer 32 is a polyester material having a thickness between about 0.5and about 1.5 mil. A silicone based adhesive layer 34 covers the filmlayer 28. Preferably, the silicone based adhesive layer 34 has athickness of between about 4 and about 8 mil, and more preferablybetween about 5 and about 7 mil. The silicone based adhesive layerfunctions as a contact surface where the electroencephalography devicecontacts the head of a patient. A release film 36 covers the siliconebased adhesive layer 34.

As used herein the term “silicone based adhesive” comprises adhesivesmade from polydimethylsiloxanes (PDMS). Some methyl groups in thepolydimethylsiloxanes can be substituted by other organic groups oratoms, for example hydrogen, hydroxyl, vinyl, polyethylene oxide,methoxy and fluoride groups, to modify the properties of the adhesive.In a preferred embodiment of the present invention, the silicone basedadhesive is the silicone based adhesive found in BIOFLEX RX1268S, soldby Scapa North America, Windsor, Conn. USA. In an additional embodimentof the present invention, the silicone based adhesive layer 34 coversthe dielectric layer 24 with no acrylic adhesive layer 30 or film layer32.

A conductive gel 38, such as KCl gel or hyrdrogel, is soaked into thesponges 28. The device 10 is placed into a tray (not shown) having aplurality of wells 40. The pre-soaked sponges sit within the wells 40 toprotect the fluid contained therein. In an additional embodiment, thewells can be filled with additional conductive gel. Alternatively, therelease film 36 has wells 40 that extend over the pre-soaked sponges 34.

In one embodiment, the device 10 is manufactured from two separatepieces. A first piece with the base layer 16, silver circuitry 18,electrodes 20, dielectric layer 24 and sponge adhesive 26 is attached toa second piece having the acrylic adhesive 30, film layer 32, siliconeadhesive layer 34 and release film 36. The second piece may be acommercially available double coated co-polyester film with a releasepaper (not shown) over the acrylic adhesive 30. Prior to attachment withthe first piece, the second piece is cut, such as with a laser, to makeholes in the second layer corresponding to the electrodes 20 and spongeadhesive 26 in the first piece, the release paper removed and theacrylic adhesive 30 coupled to the dielectric layer 24. Followingattachment of the second piece, the sponges 28 are attached to thesponge adhesive 26. In a preferred embodiment of the present invention,the double coated co-polyester film is BIOFLEX RX1268S, sold by ScapaNorth America, Windsor, Conn. USA.

The sagittal portion 14 comprises a forehead anchor 44 with an array ofpre-gelled electrodes, where the electrodes are positioned across theforehead in predetermined International 10-20 System locations, such asfor example F_(P1), F_(P2), F₇, F₈, a reference® electrode and a groundelectrode (G). The forehead anchor has a first forehead anchor arm 46and a second forehead anchor arm 48. Preferably, the first foreheadanchor arm 46 and the second forehead anchor arm 48 extend in opposingdirections. In an embodiment, the forehead anchor 44 also has a thirdforehead anchor arm 50 located between the first forehead anchor arm 46and the second forehead anchor arm 48.

A midsection 52 extends from the forehead anchor 44. The midsection 52has an anterior to posterior array of pre-gelled electrodes positionedin predetermined 10-20 locations, such as for example, F_(Z), C_(Z),P_(Z), O₁ and O₂. The midsection terminates in a neck anchor 54 at thebase of the skull (shown at the bottom of FIG. 2).

The neck anchor 54 has a first neck anchor arm 56 and a neck anchorsecond arm 58. Preferably, the first neck anchor arm 56 and the secondneck anchor arm 58 extend in opposing directions perpendicular to themidsection 52. In an embodiment, the neck anchor 54 also has a thirdneck anchor arm 60 located between the first neck anchor arm 56 and thesecond neck anchor arm 58.

The coronal portion 12 comprises an array of pre-gelled electrodespositioned in predetermined 10-20 locations, such as for example A₁, T₃,C₃, C₄, T₄ and A₂ (shown in FIG. 1 and FIG. 2). When placed on thepatient the electrodes are located transversely along the centralcoronal plane from the predetermined 10-20 location beginning at A₁ onthe left side of the head behind the left ear on the mastoid, continuingon the left side with pre-gelled electrode locations T₃ and C₃,transecting location C_(Z) of the International 10-20 System andcontinuing on the right side with pre-gelled electrode locations C₄ andT₄ and terminating at predetermined 10-20 location A₂ on the right sideof the head behind the right ear on the mastoid.

The coronal portion 12 comprises a first ear anchor 62, having a frontarm 64 configured to be placed around and in front of the left ear ofthe patient and a rear arm 66 configured to be placed around and behindthe left ear of the patient. An electrode for 10-20 location A₁ islocated on the rear arm 66. A midsection 68 extends from the first earanchor 62. The midsection 68 terminates in a second ear anchor 70. Thesecond ear anchor has a front arm 72 configured to be placed around andin front of the right ear of the patient and a rear arm 74 configured tobe placed around and behind the right ear of the patient. An electrodefor 10-20 location A₂ is located on the rear arm 74.

In an additional embodiment with reference to FIG. 4, theelectroencephalography device 10 additionally comprises one or more thanone adhesive coated stabilizing strip 76 to attach the midsection 52 ofthe sagittal portion 14 proximal to the electrodes over 10-20 locationsO₁ and O₂ to the mastoid bones of the patient. Additionally, thestabilizing strip 76 can attach the forehead anchor 44 proximal to theelectrodes over 10-20 locations F_(7 and) F₈ to the head of the patient.In an embodiment, the stabilizing strip has a base layer 82, which maybe a polyester film, covered with a silicone based adhesive 84. In anembodiment, a release film 86 covers the silicone adhesive 86.

In an additional embodiment with reference to FIG. 5, anelectroencephalography device 100 is configured to cover all of the10-20 electrode locations. The structure of this embodiment is similarto the embodiment shown in FIG. 2. However, the midsection 52 of thesagittal portion 14 is configured to provide electrodes at 10-20locations T₅ and T₆. Stabilizing strips 76 can be used to attach themidsection of 52 of the sagittal portion 14 proximal to the electrodesat 10-20 locations T₅ and T₆ to the mastoid bones of the patient.Additionally, the midsection 68 of the coronal portion 12 is configuredto provide electrodes at 10-20 locations F₃, F₄, P₃ and P₄. Stabilizingstrips 76 can be used to attach the midsection 68 of the coronal portion12 proximal to the electrodes at 10-20 locations F₃, F₄, P₃ and P₄ tothe sagittal strip or to the head of a wearer.

In additional embodiments, the electroencephalography device isconfigured with different combinations of electrodes for specificusages. For example, when configured for use in a sleep study, theelectroencephalography device may be configured so that the coronalportion has electrodes at 10-20 locations A₁, C₄, C₃ and A₂, and thesagittal portion has reference and ground electrodes and electrodes at10-20 locations F₃, F₄, C_(Z), O₁, O₂. Additionally, as will beunderstood by one of skill in the art, the electroencephalography devicemay be configured to have electrodes at locations other than 10-20locations. For example, when configured for use in an evoked potentialstudy, the sagittal portion may also be configured to have an electrodeat location O_(Z) of the 10-10 system for EEG electrode placement.

Preferably, the electroencephalography device is a disposable EEGheadpiece, that is, the electroencephalography device is inexpensiveenough to manufacture that it can be considered disposable in routineuse. Depending on the electroencephalography requirements of a givenpatient, the coronal portion 12 and the sagittal portion 14 can be usedseparately or in combination.

Kit

According to another embodiment of the present invention, there isprovided a method for performing electroencephalography. In a preferredembodiment, the method comprises providing an electroencephalographydevice according to the present invention. An example of the method willnow be disclosed with reference to FIG. 6 and FIG. 7. FIG. 6 and FIG. 7,are respectively, a top perspective view showing placement of theelectroencephalography device of FIG. 2 on the head of a patient (FIG.6); and a lateral perspective view showing placement of theelectroencephalography device of FIG. 2 on the head of a patient (FIG.7). As used in this disclosure, except where the context requiresotherwise, the method steps disclosed are not intended to be limitingnor are they intended to indicate that each step is essential to themethod or that each step must occur in the order disclosed.

First, a suitable patient is selected. In a preferred embodiment, thepatient is known to have a disease of the brain, or is suspected ofhaving a disease of the brain that can be identified or quantified byelectroencephalography. In one embodiment, the patient is known to have,or is suspected of having non-convulsive status epilepticus. In anotherembodiment, the patient is known to have, or is suspected of having anepileptic seizure. In yet another embodiment, the patient is known tohave, or is suspected of having a stroke.

Next, the sagittal portion 14 of the electroencephalography device isattached to the patient. In one embodiment, the patient's forehead iscleaned and dried, such as for example by wiping the patient's foreheadwith a gauze pad. In another embodiment, the patient's hair is partedalong the midline sagittally to expose the patient's scalp, such as forexample by using the end of a cotton-tipped applicator to part the hair.

Next, the forehead anchor 44 of the electroencephalography device 10 ispositioned over the nasion. The release film 36 is removed from theforehead anchor 44 of the electroencephalography device 10 exposing thepre-gelled, sponge covered electrodes and the electroencephalographydevice is attached to the skin of the patient's forehead. Then, theremainder of the sagittal portion 14 is attached to the scalp of thepatient by removing the remainder of the release film 36 and pressing italong the remainder of the sagittal portion 14 as the device is appliedto the C_(z) location at the vertex and posteriorly to the P_(Z), O₁ andO₂ locations on the scalp. Finally, the neck anchor 54 is attached tothe base of the skull and the back of the neck.

Next, the coronal portion 12 of the electroencephalography device 10 isattached to the patient. In one embodiment, the patient's hair is partedalong the central coronal plane towards the left ear, if necessary.Then, the release liner 36 covering a left side of the coronal portion12 of the electroencephalography device is removed, and the left side ofthe coronal portion is attached to the patient's scalp beginning at theC_(Z) location. Next, the left side of the coronal portion is attachedto the scalp and the electrodes therein secured to the scalp along theleft central plane by removing the adhesive liner toward the first earanchor 62. Next, the release liner 36 is removed from the rear arm 66 ofthe first ear anchor 62 and the rear arm 66 and the electrode for the A₁location are attached the mastoid behind the left ear. Then, the releaseliner 36 is removed from the front arm 68 of the first ear anchor 62 andthe front arm 68 is attached in front of the left ear.

Next, the hair along the central coronal plane is parted towards theright ear, if necessary. Then the release liner 36 cover a right side ofthe coronal portion 12 of the electroencephalography device is removedand the right side of the coronal portion is attached to the patient'sscalp beginning at the C_(Z) location. Next, the right side of thecoronal portion is attached to the scalp and the electrodes thereinsecured to the scalp along the right central plane by removing theadhesive liner toward the second ear anchor 70. Next, the release liner36 is removed from the rear arm 74 of the second ear anchor 70 and therear arm 74 and the electrode for the A₂ location are attached to themastoid behind the right ear. Then, the release liner 36 is removed fromthe front arm 72 of the second ear anchor 70 and the front arm 72 isattached in front of the right ear.

In one embodiment, the electroencephalography device comprises one ormore than one stabilizing strip 76 to attach the midsection 52 of thesagittal portion 14 of the electroencephalography device over themastoid bones of the patient, and the method further comprises attachingthe one or more than one strip over the mastoid bones by removing therelease liner 82 on one stabilizing strip 76, parting the hair (ifnecessary) along the plane from T₃ to O₁, attaching the stabilizingstrip 76 over the mastoid bone, attaching the stabilizing strip to thescalp toward the O₁ electrode site, and attaching the end of thestabilizing strip proximate to the O₁ electrode. Corresponding steps areperformed to attach the second strip along the plane from T₄ to O₂ andattaching the end of the second strip proximate to the O₂ electrode.

The method then comprises mating the electroencephalography device witha reusable EEG cable suitable for use with any EEG system according totechniques well known to those with skill in the art, such as forexample by connecting the connectors on the electroencephalographydevice to the reusable EEG interface cable and plugging the 10-20labeled DIN connectors at the terminal end of the EEG interface cableinto the appropriate 10-20 EEG head box locations.

The method then comprises using the electroencephalography device toobtain an electroencephalogram of the patients brain function. Once theelectroencephalogram has been obtained, the electroencephalographydevice can be removed from the patient. In an embodiment, the coronalportion 12 is removed by peeling the first ear anchor 62 and the secondear anchor 70 off from around the patient's ears. The coronal portion 12is then peeled toward the midline of the head and then back toward theback of the head to remove the coronal portion 12. The forehead anchor44 of the sagittal portion 14 is peeled away from the patient's foreheadand the sagittal portion 14 is peeled off the patient's head toward theinion.

In another embodiment of the present invention, there is provided amethod of treating a disease or condition. The method comprises, first,performing electroencephalography according to the present invention.Then, the disease or condition is diagnosed. Next, the disease orcondition that is diagnosed is treated. In one embodiment, the diseaseor condition is non-convulsive status epilepticus. In anotherembodiment, the disease or condition is an epileptic seizure. In yetanother embodiment, the disease or condition is a stroke.

In an additional embodiment, the method further comprises treating thediagnosed disease or condition. For example, if the diagnosed disease orcondition is an epileptic seizure, then treating the patient furthercomprises administering to the patient an anti-epilepsy drug, such asvalium, ativan, midazolam, fosphenetoin, lorazepam, carbamazepine,ethosuximide, Felbatol, Gabitril, Keppra, Lamictal, Lyrica, Neorontin,Phenytoin, Topamax, Trileptal, valproate, valproic acid or Zonegran.

Although the present invention has been discussed in considerable detailwith reference to certain preferred embodiments, other embodiments arepossible. Therefore, the scope of the appended claims should not belimited to the description of preferred embodiments contained in thisdisclosure. All references cited herein are incorporated by reference intheir entirety.

1. A device for performing electroencephalography on a patient, thedevice comprising: a) a sagittal portion comprising: i) a foreheadanchor comprising two arms, a first forehead anchor arm and an opposingsecond forehead anchor arm; ii) a neck anchor comprising two arms, afirst neck anchor arm and an opposing second neck anchor arm; iii) amidsection between the forehead anchor and the neck anchor; and iv) aplurality of imbedded electrodes within the forehead anchor and themidsection; b) a coronal portion comprising a plurality of imbeddedelectrodes; and c) electrical connectors for electrically connecting theimbedded electrodes in the sagittal portion and the coronal portion toan electroencephalograph.
 2. The device of claim 1, where the sagittalportion and the coronal portion each comprise a contact surface; andwhere the contact surface comprises a silicone based adhesive forreversibly attaching the device to the patient.
 3. The device of claim2, where the sagittal portion or the coronal portion or both thesagittal portion and the coronal portion each comprise a release filmcovering the contact surface.
 4. The device of claim 1, where foreheadanchor further comprises a third forehead anchor arm between the firstforehead anchor arm and the second forehead anchor arm.
 5. The device ofclaim 1, where the neck anchor further comprises a third neck anchor armbetween the first neck anchor arm and the second neck anchor arm.
 6. Thedevice of claim 1, where the imbedded electrodes in the forehead anchorare positioned at positions F₇, F_(P1), F_(P2) and F₈ of theInternational Standard 10-20 System for electrode placement. The deviceof claim 1, where the imbedded electrodes in the midsection consist ofelectrodes positioned at positions F_(Z), C_(Z), P_(Z), O₁ and O₂ of theInternational Standard 10-20 System for electrode placement.
 7. Thedevice of claim 1, where the forehead anchor further comprises areference electrode or a ground electrode or both a reference electrodeand a ground electrode.
 8. The device of claim 1, further comprising aplurality of sponges attached to the imbedded electrodes.
 9. The deviceof claim 10 where one or more than one of the plurality of spongescontains a conductive gel.
 10. A device for performingelectroencephalography on a patient, the device comprising: a) a coronalportion comprising: i) a first ear anchor comprising a front arm and arear arm; ii) a second ear anchor comprising a front arm and a rear arm;iii) a midsection between the first ear anchor and the second earanchor; iv) a plurality of imbedded electrodes within the first earanchor, the midsection and the second ear anchor; b) a sagittal portioncomprising a plurality of imbedded electrodes; and c) electricalconnectors for electrically connecting the imbedded electrodes in thesagittal portion and the coronal portion to an electroencephalograph.11. The device of claim 11, where the sagittal portion and the coronalportion each comprise a contact surface; and where the contact surfacecomprises a silicone based adhesive for reversibly attaching the deviceto the patient.
 12. The device of claim 12, where the sagittal portionor the coronal portion or both the sagittal portion and the coronalportion each comprise a release film covering the contact surface. 13.The device of claim 11, where the imbedded electrode in the first earanchor is positioned at position A₁ of the International Standard 10-20System for electrode placement.
 14. The device of claim 11, where theimbedded electrode in the second ear anchor is positioned at position A₂of the International Standard 10-20 System for electrode placement. 15.The device of claim 11, where the imbedded electrodes in the midsectionconsists of electrodes positioned at positions T₃, C₃, C₄ and T₄ of theInternational Standard 10-20 System for electrode placement.
 16. Thedevice of claim 11, further comprising a plurality of sponges attachedto the imbedded electrodes.
 17. The device of claim 17 where one or morethan one of the plurality of sponges contains a conductive gel.
 18. Adevice for performing electroencephalography on a patient, the devicecomprising: a) a sagittal portion comprising: i) a forehead anchorcomprising two arms, a first forehead anchor arm and an opposing secondforehead anchor arm; ii) a neck anchor comprising two arms, a first neckanchor arm and an opposing second neck anchor arm; iii) a midsectionbetween the forehead anchor and the neck anchor; iv) a plurality ofimbedded electrodes within the forehead anchor, and the midsection; b) acoronal portion comprising: i) a first ear anchor comprising a front armand a rear arm; ii) a second ear anchor comprising a front arm and arear arm; iii) a midsection between the first ear anchor and the secondear anchor; iv) a plurality of imbedded electrodes within the first earanchor, the midsection and the second ear anchor; and c) electricalconnectors for electrically connecting the imbedded electrodes in thesagittal portion and the coronal portion to an electroencephalograph.19. The device of claim 19, where the sagittal portion and the coronalportion each comprise a contact surface; and where the contact surfacecomprises a silicone based adhesive for reversibly attaching the deviceto the patient.
 20. The device of claim 20, where the sagittal portionor the coronal portion or both the sagittal portion and the coronalportion further comprise a release film covering the contact surface.21. The device of claim 19, where the forehead anchor further comprisesa third forehead anchor arm between the first forehead anchor arm andthe second forehead anchor arm.
 22. The device of claim 19, where theneck anchor further comprises a third neck anchor arm between the firstneck anchor arm and the second neck anchor arm.
 23. The device of claim19, where the imbedded electrodes in the forehead anchor consist ofelectrodes positioned at positions F₇, F_(P1), F_(P2) and F₈ of theInternational Standard 10-20 System for electrode placement.
 24. Thedevice of claim 19, where the imbedded electrodes in the sagittalportion midsection consist of electrodes positioned at positions F_(Z),C_(Z), P_(Z), O₁ and O₂ of the International Standard 10-20 System forelectrode placement.
 25. The device of claim 19, where the foreheadanchor further comprises a reference electrode or a ground electrode ora reference electrode and a ground electrode.
 26. The device of claim19, where the imbedded electrode in the first ear anchor is positionedat position A₁ of the International Standard 10-20 System for electrodeplacement.
 27. The device of claim 19, where the imbedded electrode inthe second ear anchor is positioned at position A₂ of the InternationalStandard 10-20 System for electrode placement.
 28. The device of claim19, where the imbedded electrodes in the coronal portion midsectionconsist of electrodes positioned at positions T₃, C₃, C₄ and T₄ of theInternational Standard 10-20 System for electrode placement.
 29. Thedevice of claim 19, further comprising a plurality of sponges attachedto the imbedded electrodes.
 30. The device of claim 30, where one ormore than one of the plurality of sponges contains a conductive gel. 31.A device for performing electroencephalography on a patient, the devicecomprising: a) a sagittal portion comprising a plurality of imbeddedelectrodes; b) a coronal portion comprising a plurality of imbeddedelectrodes; and c) electrical connectors for electrically connecting theimbedded electrodes in the sagittal portion and the coronal portion toan electroencephalograph; where the sagittal portion and the coronalportion each comprise a contact surface; and where the contact surfacecomprises a silicone based adhesive for reversibly attaching the deviceto the patient.
 32. The device of claim 32, where the sagittal portionor the coronal portion or both the sagittal portion and the coronalportion further comprise a release film covering the contact surface.33. A method of performing electroencephalography on a patient, themethod comprising: a) providing a device according to claim 1 or claim11 or claim 19 or claim 32; b) affixing the device to the patient; andc) producing an electroencephalogram.
 34. The method of claim 34, wherethe device comprises a liner; and where the method further comprisesremoving the liner before affixing the device.
 35. The method of claim34, where the device comprises a stabilizing strip; and where affixingthe device to the patient further comprises affixing the stabilizingstrip to the device and to the patient.
 36. The method of claim 34,where is provided a device of claim 19; and where affixing the device tothe patient further comprises: affixing the forehead anchor to theforehead of the patient; affixing the midsection along a sagittalmidline of the head of the patient; and affixing the neck anchor to thebase of the skull proximal the neck of the patient.
 37. The method ofclaim 37, where affixing the device to the patient further comprises:affixing the first ear anchor around the left ear of the patient; andaffixing the second ear anchor around the right ear of the patient. 38.A method of diagnosing a neurologic condition or disease, the methodcomprising: a) selecting a patient potentially with the neurologiccondition or disease; and b) performing electroencephalography on apatient according to claim 32 to produce an electroencephalogram. 39.The method of claim 39, further comprising diagnosing the neurologiccondition or disease by interpreting the electroencephalogram.
 40. Themethod of claim 40, further comprising treating the neurologic conditionor disease that is diagnosed.
 41. The method of claim 39, where theneurologic condition or disease is non-convulsive status epilepticus.42. The method of claim 39, where the neurologic condition or disease isan epileptic seizure.
 43. The method of claim 39, where the neurologiccondition or disease is a stroke.